Medicine
Naproxen 500 mg extended-release tablet
Naproxen 500 mg extended-release tablet is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Naproxen
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 75 tablets
- Manufacturers
- AlvogenTeva PharmaceuticalsUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G02CC02 Naproxen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 March 2015
- Identifiers
- RxCUI 1116320, 1116339, 1116349DailyMed set ID 9225acaa-209f-958b-2c51-9a46995dec33, 826fd9e3-22fe-408b-820c-f2b710189555, 7c22a2d6-821c-4f83-aead-e756aed930e5NDC 47781-154, 0480-0952, 24979-253Application NDA020353, ANDA075416
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 75 tablet, film coated, extended release in 1 bottle | 47781-154-75 | Alvogen | 11 March 2015 |
| 75 tablet, film coated, extended release in 1 bottle | 0480-0952-58 | Teva Pharmaceuticals | 1 November 2022 |
| 75 tablet, film coated, extended release in 1 bottle | 24979-253-68 | Upsher-Smith Laboratories | 25 April 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 11 March 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Naproxen 500 mg extended-release tablet.
Other strengths and forms of Naproxen
Clinical summary
Naproxen is a nonsteroidal anti-inflammatory drug indicated for the relief of the signs and symptoms of. It is available as tablets, delayed-release tablets and extended-release tablets for oral use. MedsAcross supplies Naproxen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about NaproxenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Naproxen prescribing information (Acella Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Naproxen 500 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.